Regulatory approvals, pending decisions, and appeals as of August 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Lenacapavir Regulatory Approval
ISL/LEN Phase 3 Development Program
At AIDS 2026, Merck and Gilead presented detailed results from the Phase 3 ISLEND trials, showing that an investigational weekly oral single-tablet treatment regimen combining islatravir (ISL) from Merck/MSD and lenacapavir (LEN) from Gilead sustained viral suppression as effectively as daily oral antiretroviral therapy (ART) at week 48; the studies will continue to week 96. This infographic features data from Gilead’s AIDS 2026 presentations on ISLEND-1 and ISLEND-2 trials.
Percentage Change in PEPFAR Prevention Expenditures, FY24 to FY25
This infographic, with data featured in amfAR’s PEPFAR Pulse study, examines the percentage change in PEPFAR prevention expenditures from FY24 to FY25. Significant challenges persist in the wake of cuts to PEPFAR programs, as the ripple effects continue to be felt across the field and organizations grapple with how to maintain services with fewer resources.
EXPrESSIVE Phase III Program Countries of Alimatravir
Seventeen countries are hosting sites for the Phase III efficacy trials of a monthly PrEP pill, called MK-8527, now known as alimatravir, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase III trials at IAS 2025 in Kigali. Alimatravir (AMI) was found to be safe and well-tolerated in Phase II clinical trials.
Years Ahead in HIV Prevention Research: Time to Market
This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.
HIV Prevention Pipeline: Products to Watch
From the People’s Research Agenda, this graphic tracks the pipeline of potential new HIV prevention options across broadly neutralizing antibodies, preventive vaccines, pre-exposure prophylaxis, and multipurpose technologies.
People’s Research Agenda 2025 Update Summary Table
The People’s Research Agenda sets out a people-centered framework for equitable and accelerated R&D and product introduction. It tracks the science, shows where investments align—or fail to align—with community-defined priorities, and spotlights critical gaps in the pipeline of prevention options needed to meet the diverse realities of all populations. View this summary table or see the full report and dashboard.
Alimatravir (AMI) Licensing Timeline
This timeline demonstrates the speed of generic licensing for alimatravir (AMI) compared to lenacapavir (LEN) and cabotegravir (CAB).
ARV-Based and Multipurpose Prevention Technology R&D Pipeline
The pipeline of non-vaccine HIV prevention products includes oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals and more. Also pictured are the range of MPTs in development that aim to reduce the risk of HIV and STIs and/or provide effective contraception for women.
The HIV Prevention Pipeline
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.